Periarticular penetration of cefazolin and clindamycin in second stage revision arthroplasty of the hip.

Periarticular penetration of cefazolin and clindamycin in second stage revision arthroplasty of the hip. - CONCENTRATE

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51548

Enrollment

Registered

2023-02-13

Start date

2022-05-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

periarticular penetration antibiotics

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older. 2. Scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis preferably during clindamycin 600mg three times a day orally for PJI, started at least 3 days before reimplantation.

Exclusion criteria

Exclusion criteria: 1. Antibiotic prophylaxis other than cefazolin 2000mg i.v. 2. Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision. 3. Clindamycin loaded bone cement in situ. 4. BMI more than 35 kg/m2.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the ratio (%) of the concentration of cefazolin and clindamycin in synovial fluid and bone tissue to serum. The ratio*s will be calculated for different time points after the infusion of the agents.	—

Secondary

Measure	Time frame
The secondary parameters are the concentration of cefazolin and clindamycin related to the MIC90 of micro-organisms that frequently causes PJI.	—

Countries

Netherlands

Outcome results